Health Endangerment

The Secretary established the health endangerment determination for the class of
i . 7 .
employees covered by this report based upon the findings summarized below.

(1) Pursuant to 42 C.F.R. § 83.13(c)(3), NIOSH established that there is a
reasonable likelihood that such radiation doses may have endangered the health
of members of the class. Pursuant to 42 C.F.R. § 83.13(c)(3)(ii), NIOSH
specifi ied a minimum duration of employment to satisfy this health endangerment
criterion as “having been employed for a number of work days aggregating at
least 250 work days within the parameters established for this class or in
combination with work days within the parameters (excluding aggregate work day
requirements) established for one or more other classes of employees in the

Cohort,’

(2) NIOSH did not identify any evidence from the petitioners or from other resources
that would establish that the class was exposed to radiation during a discrete
incident likely to have involved exceptionally high-level exposures, such as a
nuclear criticality incident, as defined under 42 C.F.R. § 83.13(c)(3)(i).

(3) The Board concurred with NIOSH’s finding that the health of the class may have
been endangered and defined the class according to the 250-workday
requirement specified under 42 C.F.R. § 83.13(c)(3)(ii).

i V. Effect and Effective Date of Designation

The Secretary submits this report on the designation of one additional class to the
SEC for review by Congress, pursuant to 42 U.S.C. §§ 7384/(14)(C)(ii) and
7384q(c)(2)(A), as amended by the Ronald W. Reagan National Defense
Authorization Act for Fiscal Year 2005, Pub. L. No. 108-375 (codified as amended in
scattered sections of 42 U.S.C.). Pursuant to 42 U.S.C. § 7384/(14)(C)(ii), as
amended by the Ronald W. Reagan National Defense Authorization Act for Fiscal
Year 2005, Pub. L. No. 108-375 (codified as amended in scattered sections of 42
U.S.C.), the|designation in this report will become effective 30 days after the date of
this report’s submission to Congress “unless Congress otherwise provides.”

VI. Administrative Review of Designation

The health endangerment determination of the designation provided in this report
may be subject to an administrative review within HHS, pursuant to 42 C.F.R. §
83.18(a). On the basis of such a review, if the Secretary decides to expand the class
of employees covered by this designation, the Secretary would transmit a
supplementary report to Congress providing the expanded employee class definition
and the criteria and fi findings on which the decision was based.

HHS Special Exposure Cohort Désignation: 4
Vitro Manufacturing



HHS Designation of Additional Members of the

Special Exposure Cohort
under the
Energy Employees Occupational Illness Compensation Program Act of 2000

Designating a Class of Employees from

Vitro Manufacturing
‘Canonsburg, Pennsylvania

eo sinlcen,

on HALT

“ewan

HHS Special Exposure Cohort Designation:
Vitro Manufacturing



I. Designation

|, Michael O. Leavitt, Secretary of Health and Human Services (Secretary), designate
the class of employees defined in Section II of this report for addition to the Special
Exposure Cohort (SEC), as authorized under the Energy Employees Occupational
Illness Compensation Program Act of 2000 PA), 42 U.S.C. § 7384q.

JAN 2 6 2003
—

Date Michael O. Leavitt

v S

ll. Employee Class Definition

All AWE employees who worked at Vitro Manufacturing in
Canonsburg, Pennsylvania, from August 13, 1942 through
December 31, 1957, for a number of work days aggregating at
least 250 work days, occurring either solely under this
employment or in combination with work days within the
parameters established for one or more other classes of
employees in the Special Exposure Cohort.

lll. Designation Criteria and Recommendations

Pursuant to 42 U.S.C. § 7384q, for the class defined in Section II of this report, the
Secretary has determined, and the Advisory Board on Radiation and Worker Health
(Board) has recommended, that

(1) itis hot feasible to estimate with sufficient accuracy the radiation dose that the
class received; and
|

(2) there i is a reasonable likelihood that such radiation dose may have
endangered the health of members of the class.

The SEC fi inal rule states in 42 C.F.R. § 83.13(c)(1) that it is feasible in two situations
to estimate the radiation dose that the class received with sufficient accuracy.’ First,
the rule states that radiation doses may be estimated with sufficient accuracy if
NIOSH has|established that it has access to sufficient information to estimate the
maximum radiation dose for every type of cancer for which radiation doses are
reconstructed that could have been incurred under plausible circumstances by any
member of the class. Alternatively, radiation doses may be estimated with sufficient
accuracy if NIOSH has established that it has access to sufficient information to
estimate the radiation doses of members of the class more precisely than a
maximum dose estimate.

The Board, pursuant to 42 U.S.C. § 7384q, advised the Secretary to designate the
class as an addition to the SEC in a letter received by the Secretary on December
22, 2008.

HHS Special Exposure Cohort Designation: 2
Vitro Manufacturing



IV. Designation Findings

Feasibility of Estimating Radiation Doses with Sufficient Accuracy

The Secretary established the feasibility determination for the class of employees
covered by this report based upon the findings summarized below.

(1) The Vitro Manufacturing facility was involved in early uranium processing work
for the manufacture of atomic weapons.

(2) NIOSH was unable to locate sufficient monitoring data or information on
radiological operations at this facility to be able to complete accurate individual dose
reconstructions for the potential internal exposures to uranium and uranium progeny
to which these workers may have been subjected.

(3) NIOSH determined that health may have been endangered for the workers
exposed tojradiation at this facility during the time period in question.

(4) 42.C. Fi R. § 83.14-permits a NIOSH-initiated SEC petition when NIOSH has
attempted to conduct a dose reconstruction for a cancer claimant and finds that the
dose reconstruction cannot be completed because there is insufficient information to
estimate the radiation doses of the claimant with sufficient accuracy. NIOSH
reached this conclusion for a claimant from Vitro Manufacturing, Canonsburg, PA,
and subsequently notified the claimant and provided information to the claimant
about the SEC petitioning process.

(8) Pursuant to 42 C.F.R. § 83.13(c)(1), NIOSH determined that there is insufficient
information to either: (1) estimate the maximum radiation dose, for every type of
cancer for which radiation doses are reconstructed, that could have been incurred
under plausible circumstances by any member of the class; or (2) estimate the
tadiation doses of members of the class more precisely than a maximum dose
estimate.

(6) The Board concurred with the NIOSH evaluation and recommended the
proposed class for addition to the SEC.

(7) Although NIOSH found that it is not possible to completely reconstruct radiation
doses for these employees, NIOSH intends to use any available internal and external
monitoring data that may be available for an individual claim (and can be interpreted
using existing NIOSH dose reconstruction processes or procedures). Further,
NIOSH has determined that occupational medical dose for all workers can be
reconstructed. Therefore, partial dose reconstructions for individuals with non-
presumptive) cancers or fewer than 250 days employment in the class period may be
performed using these data as appropriate.

HHS Special Exposure Cohort Designation: 3
Vitro Manufacturing